Occlutech Sizing Balloon - Catheter, intravascular, morphological measurement

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Dostępny od:

Life Systems Medical Pty Ltd

Klasa:

Class III

Wyprodukowano przez:

Occlutech GmbH Winzerlaer Strasse 2, Jena, 07745 Germany

Dziedzina terapeutyczna:

44889 - Catheter, intravascular, morphological measurement

Wskazania:

The balloon contains three X-ray compatible marker bands which function as radiographic measurement reference. The balloon is introduced transcutaneously over a guidewire to the defect and inflated until either a slight constriction is identified or blood flow stopped. Two different methods can be used to carry out a measurement with the sizing balloon: Radiography or echocardiography. The Occlutech Sizing Balloon is intended to assist determining the size of a cardiac septal defect. Used in combination with radiographic or echocardiographic imaging, the Occlutech Sizing Balloon is intended to aid in selecting an appropriate size for a cardiac implant for the closure of a septal defect. The Occlutech Sizing Balloon is intended for venous access, used without a guide catheter and introduced directly via a guide wire.

Status autoryzacji:

A

Data autoryzacji:

2012-12-04